FDA Will Not Regulate All Medical Monitoring Apps, Officials Say

Federal regulators plan to loosen regulations on medical devices, specifically medical apps and software, as well as wearable health technology, as part of an ongoing effort to encourage further development.

The editorial was written by FDA Commissioner Scott Gottlieb, MD; Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health; and Bakul Patel, associate director of the FDA’s new center on Digital Health, focusing on new health technologies, such as mHealth (mobile health), wearable trackers, telehealth and telemedicine, as well as personalized medicine.

Gottlieb and the co-authors claim the agency is too slow in approving new medical health tech and apps, indicating that these technologies can often help change patient health for the better. It can also help to integrate technology into healthcare more quickly.

“Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” the FDA officials wrote.

Mobile apps are used frequently to promote wellness, treat some diseases, diagnose others, and help manage patient care, but regulation is still unclear. The 21st Century Cures Act was amended in 2016 to change the definition of “device” to exclude some software functions. However, others are still regulated.

The FDA officials announced a new proposed guidance (PDF) designed to encourage further development of medical health technologies and software by loosening restrictions on development and approval.

The proposed guidance currently indicates that not all these technologies would be subject to FDA regulation. However, the FDA does oversee most mobile apps that are intended as medical devices.

If the tech is intended to treat, diagnose, cure, mitigate, or prevent disease it is overseen by the FDA. However, not all apps meet these characteristics. Some are more benign in nature and simply track or record medical data, not intended to treat a disease.

Under the new proposed guidelines, the FDA will restrict the oversight of medical apps and software only if they present a serious threat to patient harm or safety.

Developers release new medical apps by the thousands each year. With the proposed guidelines, a new cycle of product approval can be compressed allowing for more so-called mHealth technologies, which may benefit patients by getting to the market sooner.

The FDA also plans to test pilot a pre-certification program, which will allow developers to become accredited, instead of having each product go through separate regulatory reviews. The accreditation would presumably be based on the quality of overall software design, testing protocols, and the developer’s overall track record. This too would allow potentially beneficial software to come to market quicker.

“Mobile medical apps may help overcome the siloed, episodic, reactive nature of US health care, whereby patients seek care only after potentially costly health complications occur, and physicians are only reimbursed for expensive in-person office visits that may not reflect the day-to-day reality of the patient experience of living with complex chronic conditions,” wrote the FDA officials.

The proposed regulation will be open for public comment until June 28.